DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Terminal Disclaimer
Terminal disclaimer is disapproved. The applicant name is incomplete on the TD form filed on 05/27/2026. To resolve disapproval please resubmit and type the applicant name above the line/space on the form or send attachment on a separate page. No additional fee is required with the resubmission.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 58-60 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 9-11 of prior U.S. Patent No. 11,542,555. This is a statutory double patenting rejection.
Claim 58 recites a method of treating a human patient suffering from heart failure with reduced ejection fraction, and with reduced Bcl-2 associated anthanogene-3 (BAG3) expression, comprising: administering to the human patient's heart a therapeutically effective amount of an isolated BAG3 gene, BAG3 polynucleotide, BAG3 protein, BAG3 polypeptide or an expression vector comprising a BAG3 polynucleotide or cDNA sequence thereof, wherein the expression vector further comprises a muscle specific promoter, to increase expression or amount of BAG3 polypeptides or proteins in the human patient's heart, further comprising cardiac specific promoter. Claim 9 from '555 recites identical method, except for recitation "with reduced Bcl-2 associated anthanogene-3 (BAG3) expression" it states "wherein the human patient expresses a decreased level of Bcl-2 associated anthanogene-3 (BAG3) polynucleotide or polypeptide", which is a different way to express the same statement. Cardiac promoter is a type of muscle specific promoter, therefore, scopes of instant claim 58 and claim 9 from '555 are identical.
Claims 59-60 all originally depend on claim 58 and add identical limitations as claims 10- 11, respectively, from '555, which all originally depend on claim 9 from '555, therefore scopes of dependent claims are respectively identical as well.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 50-66, 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/736260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '260 recite treatment of patient suffering from heart failure with reduced ejection fraction by administering nucleic acid ncoding BAG3 polypeptide, same as in instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 50-66, 68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,516,376 (issued Application No. 16/973,353). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '376 recite treatment of patient suffering from heart failure by administering expression vector encoding BAG3 polypeptide, same as in instant claims. Further, specification of '376 teach that heart failure with reduced ejection fraction can be treated by claimed method (see lines 1-5 in column 6) and muscle specific promoters can be used (see lines 60-65 in column 18).
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Concerning statutory double patenting rejection Applicant argues that new amendment overcomes the rejection. In response the rejection of claims 50-57, 61-66, 68 is withdrawn based on new amendment. Claims 58-60 are still rejected as explained above.
Concerning double patenting rejection over Application No. 18/736260 Applicant argues that terminal disclaimer was filed, overcoming the rejection. In response terminal disclaimer was not accepted, thus rejection is maintained.
Concerning double patenting rejection over Application No. 16/973353, now US Patent 12516376, Applicant argues that instant claims are broader than claims from 12516376. In response claims from 12516376 are directed to particular BAG3 variants, but the methods of treatment are the same. Therefore, claims from 12516376 anticipate instant claims. Rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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